Subsection 56 (1) of the Controlled Drugs and Substances Act (CDSA) allows exemptions for possession of controlled substances to be applied under the Act, for a person or class of persons. Controlled substances are drugs which are determined by the federal government as having a higher potential for abuse or addiction. An exemption may be granted if the Minister of Health deems it necessary for a medical or scientific purpose, or if the exemption is otherwise in the public interest. Non-government persons allowed under the CDSA, Food and Drug Regulations to possess a scheduled (restricted) drug are a licensed dealer, a qualified investigator (i.e., for running clinical trials or conducting lab research in an institution), and a person exempted for possession of a drug. This summary addresses some key requirements for obtaining and holding a federal dealer’s licence.
An applicant wanting to produce a controlled substance needs a CDSA dealer licence. As noted in Division 2 of the Food and Drug Regulations, a licensed dealer is authorized to produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug.
An applicant wanting to produce a controlled substance needs a CDSA dealer licence. As noted in Division 2 of the Food and Drug Regulations, a licensed dealer is authorized to produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug. The permitted production activities of this licence include synthesis, extraction, purification and compounding of controlled substances. The dealer may have to meet additional licensing requirements to make dose forms for human consumption. Dealer’s licence requirements differ from section 56 exemptions for persons seeking to administer a controlled substance for research purposes (they need a site-specific exemption). Requirements and approvals also differ for exemptions to allow compassionate access, where access to restricted drugs may be granted through the Special Access Program. Applicants are limited to an individual who ordinarily lives in Canada; a corporation with its head office or a branch office in Canada; or a person holding a position responsible for controlled drugs on behalf of the Canadian Government, a provincial government, a police force, a hospital or a Canadian university.
A dealer’s licence application must designate only one individual as the Senior Person in Charge, who has overall responsibility for managing the activities with controlled drugs as specified in the application. A person who has been convicted of a designated substance or criminal offence (as defined under the Cannabis Act) within 10 years prior to submitting the application, is not eligible to hold the position. The applicant must also identify one Qualified Person in Chargewho will be responsible for supervising activities involving the drugs specified in the licence application. An Alternate Qualified Person in Charge may be proposed to replace the qualified person in charge, provided they meet equivalent job criteria. The application requests specific information regarding the manufacturing and use of products and compounds. These include product brand name, the drug name and strength proposed for the product or compound, the strength per unit, expected quantity to be made and many other stipulations. In addition to these requirements, applicants must comply with security and record-keeping provisions and obtain a permit each time they export or import controlled substances. The purchase and sale of controlled substances (such as psychedelics) by a licenced dealer must be pre-approved by Health Canada.
Once both the dealer and the purchaser have been authorized to complete a transaction, the licensed dealer may provide the controlled substance to the research institution or company for the purpose of performing research and conducting clinical trials.When the dealer licence expires it may be renewed subject to any terms and conditions imposed the Minister. These are stipulated in order to comply with international obligations, ensure conformity with the appropriate security level, and reduce risks to public safety such as diversion to illicit markets.